ABX PENTRA 400: LIPOPROTEINS

Calibrator, Secondary

HORIBA ABX

The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra 400: Lipoproteins.

Pre-market Notification Details

Device IDK060854
510k NumberK060854
Device Name:ABX PENTRA 400: LIPOPROTEINS
ClassificationCalibrator, Secondary
Applicant HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault,  FR 34184
ContactTim Lawton
CorrespondentTim Lawton
HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault,  FR 34184
Product CodeJIT  
Subsequent Product CodeCDT
Subsequent Product CodeCHH
Subsequent Product CodeJJY
Subsequent Product CodeLBR
Subsequent Product CodeMRR
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-29
Decision Date2006-08-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610230007099 K060854 000
03610230007044 K060854 000
03610230005095 K060854 000
03610230005743 K060854 000
03610230005033 K060854 000
03610230005019 K060854 000
03610230004999 K060854 000
03610230004975 K060854 000

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